Phase 2
N=190
Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation
Constipation · Chronic Constipation
Bottom Line
View on ClinicalTrials.gov: NCT01007123 ↗Enrolled (actual)
190
Serious AEs
1.6%
Results posted
Mar 2017
Primary outcome: Primary: Change From Baseline in Frequency of Spontaneous Bowel Movements — 2.5; 4.0; 5.4; 1.7 Number of SBMs — p=<0.2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- A3309 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Albireo
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Frequency of Spontaneous Bowel Movements |
2.5; 4.0; 5.4; 1.7 | <0.2 |
| SECONDARY Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs) |
25; 27; 30; 14 | 0.03 sig |
| SECONDARY Time to First Bowel Movement |
23; 12; 7; 27 | 0.06 |
| SECONDARY Stool Consistency Change From Baseline |
0.91; 1.52; 1.91; 0.66 | 0.44 |
| SECONDARY LDL/HDL Ratio |
-0.10; -0.27; -0.21 | 0.01 sig |
| SECONDARY Straining Change From Baseline |
-0.84; -1.13; -1.15; -0.64 | 0.17 |
Summary
The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.
Eligibility Criteria
Inclusion Criteria
- Patient meets protocol specified criteria for constipation
- Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests and colonoscopy as applicable
Exclusion Criteria
- Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study
- Patient reports loose stools
- Patient has IBS with pain/discomfort as predominant symptom
- Patient needs medications prohibited as specified in the protocol
Data sourced from ClinicalTrials.gov (NCT01007123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.